“Within the make-up of human beings, intelligence counts for greater than our arms, and that’s our true power.”
Ovid Therapeutics (OVID) is a younger biopharmaceutical firm that was founded in 2014 and went public in 2017. The main target of the corporate is uncommon illnesses in Neuroscience. Given my medical curiosity in autism, I’ve had a number of requests to write down about this firm resulting from their main targets of Fragile X and Angelman Syndromes. These syndromes are each related to autistic signs and can be mentioned in additional element beneath.
Ovid Has a Robust Management Group
I don’t routinely talk about the standard of the management/administration in my articles resulting from the truth that I often concentrate on the science. Nonetheless, one of many first optimistic qualities that jumps out about Ovid is the power of their management workforce. This begins with the CEO and Chairman of the Board, Dr. Jeremy Levin. Dr. Levin is most well-known for his brief keep as CEO of Teva (TEVA), however a few of his greatest work got here previous to that at Bristol Myers-Squibb (BMY) and Novartis (NVS). He reportedly chose to lead Ovid over a number of different gives after leaving Teva. One of many key facets of this alternative was the power to kind the corporate tradition in his fashion with out pre-set notions. A part of this tradition might be seen within the firm’s “Become an Ovidian” web page that features the truth that Ovidians are “Foosball Fanatics” and “Chocolate Connoisseurs.”
Past Dr. Levin, the management has four M.D.’s together with its founder and Chief Scientific Officer, Dr. Matthew Throughout. The CMO (Dr. Amit Rakhit) and CFO (Dr. Yaron Werber) are each holders of twin MD and MBA levels. Dr. Rakhit was previously a Senior Vice President at Biogen (BIIB) and Vice President at Bristol Myers-Squibb. Dr. Werber was a managing director at Citigroup International Markets and led the healthcare/biotech analysis groups there. Previous to that, he was a VP and senior biotech analyst at SG Cowen. The fourth MD on the workforce is Dr. Claude Nicaise who’s over orphan regulatory affairs.
A full itemizing of the Ovid Group might be discovered on their web page and contains a number of others with backgrounds at firms reminiscent of Lundbeck, ImClone (Eli Lilly), Forest Labs, and a HR Director that used to carry that place for the Blue Man Group.
Ovid and its management is taking a singular method to drug acquisition and growth. They’re doing this by specializing in buying medicine (or stakes in medicine) which have been put apart by different firms, however they see as having important potential in neuroscience uncommon illnesses.
OV101 – From Failed Insomnia Drug to Hope for Uncommon Genetic Ailments
The primary compound that Ovid acquired was OV101, which it obtained worldwide rights to from Lundbeck. OV101 is gaboxadol, which first synthesized in 1977 by Povl Krogsgaard-Larsen. Nonetheless, it wasn’t till the late 1990’s and early 2000’s that Lundbeck and Merck (MRK) targeted growth efforts for the drug to be used in insomnia. Gaboxadol is a extremely selective GABAA receptor agonist and was recognized to have a sedative impact when examined in early research for Alzheimer’s, Huntington’s, and Tardive Dyskinesia. Due to this fact, Lundbeck and Merck felt that it will make a superb sedative/hypnotic and notably focused a rise in Stage four (deep) sleep. Nonetheless, research didn’t present a major optimistic impact on sleep as anticipated and had a better price of unwanted side effects. Notably regarding unwanted side effects have been hallucinations and disorientation. In consequence, Lundbeck/Merck cancelled the drug’s development in 2007. The drug then sat on the shelf for a number of years till Ovid acquired it in early 2015.
Ovid is testing OV101 in each Angelman Syndrome and Fragile X Syndrome. Each of those are neurodevelopmental issues which have a presentation that features autistic signs. Angelman Syndrome entails chromosome 15 and is most often a small deletion of the ubiquitin protein ligase E3a (UBE3A) gene. This results in a lack of expression of the related protein, which in flip results in elevated GABA Reuptake. Fragile X Syndrome outcomes from mutations of the delicate X psychological retardation 1 (FMR1) gene. Mutations of this gene result in the lack of expression of the related protein, which in flip results in lower GABA launch. Due to this fact, each situations in the end end in much less GABA within the synapses between neurons. GABA is an inhibitory neurotransmitter and subsequently lack of GABA leads to much less inhibition, which ends up in overactivity of the neurons and related signs. These concurrent pathways are effectively diagrammed within the following graphics from Ovid’s Corporate Presentation (web page 9):
Ovid believes that the selective agonistic results of OV101 on the postsynaptic GABA receptors will end in improved signs for sufferers with each Angelman and Fragile X. Ovid has superior OV101 into two Part 2 Research for Angelman Syndrome – one in adults and one in adolescents. They’re additionally planning to advance research in youthful kids. They’re nearing initiation of a Part 2 Research of OV101 in Fragile X.
The research in Angelman Syndrome have had a really optimistic preliminary reception as indicated by the necessity for suspension of on-line curiosity kinds on the study website in addition to feedback by the CEO. There are 13 sites the place analysis is being performed for the examine, 12 of that are in america and 1 in Israel. The first end result measure is expounded to tolerability, however there are 17 secondary measures together with bodily, behavioral, and sleep-related signs. A key issue to look at would be the main end result measure because it pertains to the potential opposed occasions of hallucinations and disorientation. Given the neurodevelopmental nature of the illness, these signs might or might not present up as reported unwanted side effects. Nonetheless, elevated behavioral unwanted side effects (notably aggression or self injurious habits) may very well be anticipated if these signs have been occurring. Any important improve in hallucinations, disorientation, aggression, or self injurious behaviors as a aspect impact could be a pink flag for future OV101 research.
OV935 Offers Ovid a Stable Partnership and A number of Potential Uncommon Illness Targets
Ovid’s second compound is OV935 (aka TAK-935), for which Ovid acquired a 50% stake in a partnership cope with Takeda (OTCPK:TKPYY) (OTCPK:TKPHF). OV935 is a selective ldl cholesterol 24-hydroxylase (CH24H) inhibitor. On this relatively distinctive true partnership, Takeda agreed to permit Ovid to conduct analysis on Takeda’s compound that had accomplished Part 1 research, however was not a precedence for Takeda. Ovid and Takeda agreed to 50-50 funding and 50-50 income break up for all future growth of OV935 for uncommon pediatric seizure situations. This settlement may very well be expanded to cowl different potential indications. Commercialization could be break up with Takeda being chargeable for Japan and sure all of Asia, whereas Ovid would market in North America, Europe, and Israel.
Ovid has initiated a Phase 1b/2a study of OV935 to guage the security of the compound in adults with developmental or epileptic encephalopathies which are taking different seizure treatment. The examine is just searching for 20 individuals and lasts 4 months per clinicaltrials.gov. Ovid plans to ultimately work in the direction of finding out OV935 in uncommon pediatric epilepsies together with Dravet Syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Advanced. Dravet Syndrome leads to intractable seizures beginning round 1 12 months of age and is often brought on by a genetic mutation leading to irregular ion channels. It’s usually thought of a catastrophic illness with no ample therapy and results in important developmental delays. Lennox-Gastaut Syndrome is one other troublesome to deal with epilepsy that has a attribute EEG sample. It’s not usually as catastrophic as Dravet Syndrome, however does usually end in mental incapacity. There was some progress made in therapy of LGS, however higher remedies are nonetheless wanted. Lastly, Tuberous Sclerosis Advanced is a various illness that features benign tumor progress in lots of elements of the physique. It will possibly fluctuate considerably in severity relying on which physique organs are impacted. When these benign tumors develop within the mind it will possibly produce seizures reminiscent of childish spasms. There might be all kinds of developmental/behavioral displays together with signs of ADHD, Autism Spectrum Problems, studying disabilities, and/or mental disabilities.
If Ovid and Takeda may very well be profitable in treating the seizures of any of those three syndromes, then OV935 may very well be a extremely profitable drug. Of the three, Dravet Syndrome might be the most important want whereas Tuberous Sclerosis is probably the most prevalent. Ovid has obtained Orphan Drug Designation for OV935 for each Dravet Syndrome and Lennox-Gastaut Syndrome. I count on Ovid to advance OV935 into Part 2b research for no less than these two syndromes assuming the Part 1b/2a examine doesn’t convey up any important considerations.
Is Ovid Value an Funding?
Ovid has a number of qualities which are interesting to seasoned biotech traders. They’ve a stable administration, a number of medicine and a number of potential indications and a transparent imaginative and prescient. Nonetheless, in addition they have a comparatively excessive valuation (~$200 million) for a corporation at their stage of growth. Due to this fact, it’s fairly clear that traders are betting on the power and expertise of the administration right here.
Ovid at this level in growth is a really speculative funding. Like most, I discourage inserting a good portion of a portfolio in anyone speculative inventory. Nonetheless, there’s a place in each biotech portfolio for some small speculative investments. Ovid is the kind of firm that I usually have a look at for this kind of place given its administration and portfolio. That stated – the one main catalyst in 2018 will possible be the STARS high line information for Angelman Syndrome within the 2nd half of 2018. I’d suspect that this can be 4Q 2018 though it may very well be earlier if Ovid broadcasts completion of enrollment within the close to future.
Ovid has money that ought to final them till mid-2019 at present burn charges. Nonetheless, that might imply opportunistic dilution is feasible sooner or later in mid-to-late 2018. Given the place the market cap is, the latest run-up, and the general market, I consider that there’ll virtually actually be a greater shopping for alternative sooner or later within the subsequent Three-6 months than the present worth of $eight.49 (shut Three/9/18). A pullback to the $6.50-7 space would make me extra possible so as to add a place (if that space held once more). I might additionally think about including with any secondary providing that was at $6.50 or better (together with in the event that they have been capable of do a well-subscribed secondary round $eight).
I consider the way forward for Ovid is more likely to be butterflies than moths, but it surely’s additionally okay to attend on the perfect shopping for alternative whereas we patiently wait on the cocoons.
“Be affected person and hard; in the future this ache can be helpful to you.”
― Ovid, Metamorphosis
Creator’s notice: Thanks for studying my article. Please observe me for extra articles protecting the biotech house with an emphasis on neuroscience. As all the time, I’ll disclose beneath which drug firms I’ve talked about within the article for which I’m the recipient of direct advertising and marketing. My articles embrace my private opinions and are neither monetary nor medical recommendation. They’re solely meant to indicate my perspective and due diligence on a given topic. Please seek the advice of with the right skilled if you’re in search of particular recommendation on your scenario.
Disclosure: I/we now have no positions in any shares talked about, and no plans to provoke any positions inside the subsequent 72 hours.
I wrote this text myself, and it expresses my very own opinions. I’m not receiving compensation for it (apart from from Looking for Alpha). I’ve no enterprise relationship with any firm whose inventory is talked about on this article.
Extra disclosure: I’ve had ~1-2 advertising and marketing lunches offered to my workplace previously 12 months by Takeda and extra ones previous to that. Previous to the final 5 years, I’ve had advertising and marketing lunches offered by Merck, Novartis, and Bristol Myers that included the receipt of pens and different small gadgets. I’ve by no means been paid by any pharma/biotech firm for talking or writing articles.